Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.

Coloplast

Status: Completed

Conditions: Stoma Ileostomy

Treatments: Device: CP381

Study type: Interventional

Funder types: Industry

Identifiers

NCT07316530

CP381

Details and patient eligibility

About

Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively.

Among the main reasons for developing PSCs are that the peristomal skin is exposed to stomal output either due to leakage of output under the baseplate and/or imperfect cutting of the hole in the baseplate, and incorrect application creating a gap between the hole in the baseplate and the stoma.

To seal this gap, Coloplast has developed a new ostomy baseplate and the aim of the investigation is to explore the investigational device 's ability to help protect the peristomal skin.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has given written informed consent
• Is at least 18 years old
• Has full legal capacity
• Has an ileostomy with consistent liquid faecal output (6-7 Bristol scale).
• Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days before the inclusion.
• Has had the stoma for at least 90 days
• Has a stoma size less than 45mm in diameter
• Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last 14 days
• Has suitable peristomal skin area (assessed by investigator) to participate in investigation
• Is willing to refrain from analgesics within 24 hours before the test days
• Is willing to refrain from antihistamine within 96 hours before the test days
• Is willing to refrain from steroid treatment within 24 hours before the test days

Exclusion criteria

• Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.
• low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
• Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray.
• Is breastfeeding
• Is pregnant based on urine pregnancy test.
• Has known hypersensitivity towards any of the devices used in the investigation.
• Participates in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Investigational device

Experimental group

Description:

1 day treatment with investigational device

Treatment:

Device: CP381

Comparator

Active Comparator group

Description:

1 day treatment with comparator

Treatment:

Device: CP381